A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929577
• Other study ID #: 015K-CL-PK09
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2013
• Last updated: September 13, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).

• Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.

• Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.

• Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.

• Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.

• Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.

Exclusion Criteria:

• Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.

• Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.

• Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.

• Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).

• Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.

• Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) prior to day -1 of treatment period 1.

• Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic check-in on day -1 of treatment period 1.

• Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.

• Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.

• Subject received any vaccine within 60 days prior to study drug administration.

• Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.

• Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability of ASP015K
• Food Effect of ASP015K
• Healthy Subjects
• Pharmacokinetics of ASP015K

Intervention

Drug:
• ASP015K
oral tablet

Locations

Country	Name	City	State
United States	Parexel - Early Phase Clinical Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.	Janssen Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter of ASP015K: Cmax	Maximum Concentration (Cmax)	Day 1-4 of each treatment period	No
Primary	Pharmacokinetic parameter of ASP015K: AUClast	Area Under the Curve from time zero to the last measurable time (AUClast)	Day 1-4 of each treatment period	No
Primary	Pharmacokinetic parameter of ASP015K: AUCinf	Area Under the Curve from time zero extrapolated to infinity (AUCinf)	Day 1-4 of each treatment period	No
Secondary	Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2	Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)	Day 1-4 of each treatment period	No
Secondary	Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2		Day 1-4 of each treatment period	No
Secondary	Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements		Up to Day 4 in each treatment period	No